Industry proposal for a simplified registration process of complex and innovative raw materials in Europe

Industry has come together through BioPhorum to propose a pragmatic and simple solution to the challenges it faces with the registration of complex and innovative raw materials (RMs) in Europe.

The regulatory environment for the registration of innovative and complex materials diverges across different regions and countries. Whereas most national health agencies (NHAs) provide a knowledge platform where information on non-compendial materials can be provided by raw material suppliers, Europe does not. The biopharmaceutical industry is a constant user of these non-compendial materials that enter the preparation and manufacture of its products. An example of these materials is the cell culture media used to grow and multiply cell cultures to produce complex proteins and monoclonal antibodies.

Cell culture media are a complex mix of metals, amino acids, solubilizers and/or emulsifiers to keep all components in a stable physical state, and peptones. It is not rare for a cell culture medium to be composed of over 100 individual components. Cell culture media may be chemically defined (i.e. the entire composition is fabricated) or contain some natural product (for example, fetal bovine serum or human serum albumin). Intellectual property associated with cell culture media and other innovative and complex RMs also used by the industry is high, as is their impact on performance, robustness, and quality of product and process quality. These two aspects mean that sharing of information between suppliers and end-users has always been cautious, with a careful balance between information useful for end-users and supplier proprietary information. In addition, the NHAs, including the European ones, need to ensure that products proposed to their markets are safe, efficacious and of appropriate quality. Therefore, they require sufficient information to perform their assessment.

This paper proposes a solution, applicable to all innovative and complex RMs, for which intellectual property can continue to be fostered, as well as drive higher quality regulatory submissions. The biopharmaceutical industry has designed not only a direct solution to the issue but also a way to higher quality regulatory
submissions, enhanced knowledge, understanding, control and robustness of its products and processes. The proposal has not been designed for added complexity in regulatory submissions but to provide information that is more relevant to the impact of RMs on product and process quality.

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  • Create Date 25th October 2021
  • DOI https://doi.org/10.46220/2021REG004
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